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NCT01533467 Clinical Trial

A Device Designed to Protect the Perineum During Labor

Perineal Tear Clinical Trial

Official title:
Study of Perineal Protection Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01533467
Other study ID # KH-HBG-12
Secondary ID 148/2008
Status Completed
Phase Phase 2
First received February 6, 2012
Last updated February 12, 2012
Start date November 2010
Est. completion date November 2011

Study information
Verified date February 2012
Source Helsingborgs Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

Objective:

To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.

Design:

A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.

Main outcome measures:

The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.

Description:

Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Vaginal delivery

Exclusion Criteria:

- Age below 18 years and no understanding of written and oral information.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Perineal protection device
Use of the device during delivery and inspection afterwards to see the tears.

Locations
Country Name City State
Sweden Knut Haadem Helsingborg

Sponsors (3)
Lead Sponsor Collaborator
Helsingborgs Hospital Lund University Hospital, Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Grade I and II rupture during delivery Number and extension of perineal tears during delivery time at the delivery department (up to 12 months) Yes
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